0 Ratings
ID

24026

Description

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Laboratory Collections

Keywords

Versions (1)
  1. 7/23/17 7/23/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 23, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Laboratory Collections

    English

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Laboratory Collections

    1 forms  
    Clinical Chemistry and Haematology
    Description

    Clinical Chemistry and Haematology

    Alias
    UMLS CUI-1
    C0008000
    UMLS CUI-2
    C0018941
    Exact date an time of blood sampling
    Description

    blood sampling date and time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Comments:
    Description

    comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Are there any CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
    Description

    hematology

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0205307
    UMLS CUI [2,1]
    C0018941
    UMLS CUI [2,2]
    C0205307
    Urinanalysis
    Description

    Urinanalysis

    Alias
    UMLS CUI-1
    C0042014
    Exact date and time of urine sampling
    Description

    urine sampling date and time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Comments:
    Description

    comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record on Baseline Signs and Symptoms page.
    Description

    urinanalysis normal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0205307
    Drug Screening (Urine)
    Description

    Drug Screening (Urine)

    Alias
    UMLS CUI-1
    C0202274
    Exact date and time of urine sampling
    Description

    urine sampling date and time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Were there any contra-indicated drugs detected? If YES, please record all the relevant contra-indicated drugs below.
    Description

    drug screening positive

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C1446409
    Type of drug
    Description

    drug type

    Data type

    text

    Alias
    UMLS CUI [1]
    C0457591
    Comment
    Description

    comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    HIV and Hepatitis B & C
    Description

    HIV and Hepatitis B & C

    Alias
    UMLS CUI-1
    C0019682
    UMLS CUI-2
    C0019163
    UMLS CUI-3
    C0019196
    Exact date and time of blood sampling
    Description

    blood sampling date and time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Comments:
    Description

    comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Alcohol Breath Test
    Description

    Alcohol Breath Test

    Alias
    UMLS CUI-1
    C0202306
    Exact date and time of test
    Description

    alcohol breath test date and time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Alcohol breath test positive or negative? If positive please withdraw from the study.
    Description

    alcohol breath test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0202306
    Urine Cotinine Test
    Description

    Urine Cotinine Test

    Alias
    UMLS CUI-1
    C1697737
    Exact date and time of test
    Description

    If positive please withdraw from the study.

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C1697737
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Serum b-HCG Pregnancy Test (Females only)
    Description

    Serum b-HCG Pregnancy Test (Females only)

    Alias
    UMLS CUI-1
    C0430060
    Was a pregnancy test carried out?
    Description

    pregnancy test

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0430060
    If NO, please specify reason
    Description

    pregnancy test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0430060
    If YES, please indicate date and time of test and result: Date and Time of pregnancy test:
    Description

    pregnancy test date and time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0430060
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    If YES, please indicate date and time of test and result:
    Description

    If POSITIVE, withdraw the subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0430060
    Laboratory name, if applicable
    Description

    Ensure result is included on laboratory report

    Data type

    text

    Alias
    UMLS CUI [1]
    C1882331
    Back to the top of the page

    Similar models

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Laboratory Collections

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Clinical Chemistry and Haematology
    C0008000 (UMLS CUI-1)
    C0018941 (UMLS CUI-2)
    blood sampling date and time
    Item
    Exact date an time of blood sampling
    datetime
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    comment
    Item
    Comments:
    text
    C0947611 (UMLS CUI [1])
    hematology
    Item
    Are there any CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
    boolean
    C0008000 (UMLS CUI [1,1])
    C0205307 (UMLS CUI [1,2])
    C0018941 (UMLS CUI [2,1])
    C0205307 (UMLS CUI [2,2])
    Item Group
    Urinanalysis
    C0042014 (UMLS CUI-1)
    urine sampling date and time
    Item
    Exact date and time of urine sampling
    datetime
    C0200354 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    comment
    Item
    Comments:
    text
    C0947611 (UMLS CUI [1])
    urinanalysis normal
    Item
    Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record on Baseline Signs and Symptoms page.
    boolean
    C0042014 (UMLS CUI [1,1])
    C0205307 (UMLS CUI [1,2])
    Item Group
    Drug Screening (Urine)
    C0202274 (UMLS CUI-1)
    urine sampling date and time
    Item
    Exact date and time of urine sampling
    datetime
    C0200354 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    drug screening positive
    Item
    Were there any contra-indicated drugs detected? If YES, please record all the relevant contra-indicated drugs below.
    boolean
    C0202274 (UMLS CUI [1,1])
    C1446409 (UMLS CUI [1,2])
    drug type
    Item
    Type of drug
    text
    C0457591 (UMLS CUI [1])
    comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    HIV and Hepatitis B & C
    C0019682 (UMLS CUI-1)
    C0019163 (UMLS CUI-2)
    C0019196 (UMLS CUI-3)
    blood sampling date and time
    Item
    Exact date and time of blood sampling
    datetime
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    comment
    Item
    Comments:
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Alcohol Breath Test
    C0202306 (UMLS CUI-1)
    alcohol breath test date and time
    Item
    Exact date and time of test
    datetime
    C0202306 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    Alcohol breath test positive or negative? If positive please withdraw from the study.
    text
    C0202306 (UMLS CUI [1])
    alcohol breath test
    Code List
    Alcohol breath test positive or negative? If positive please withdraw from the study.
    CL Item
    Positive (Positive)
    CL Item
    Negative (Negative)
    Item Group
    Urine Cotinine Test
    C1697737 (UMLS CUI-1)
    urine cotinine test date and time
    Item
    Exact date and time of test
    datetime
    C1697737 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item Group
    Serum b-HCG Pregnancy Test (Females only)
    C0430060 (UMLS CUI-1)
    pregnancy test
    Item
    Was a pregnancy test carried out?
    boolean
    C0430060 (UMLS CUI [1])
    pregnancy test
    Item
    If NO, please specify reason
    text
    C0430060 (UMLS CUI [1])
    pregnancy test date and time
    Item
    If YES, please indicate date and time of test and result: Date and Time of pregnancy test:
    datetime
    C0430060 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    If YES, please indicate date and time of test and result:
    text
    C0430060 (UMLS CUI [1])
    alcohol breath test
    Code List
    If YES, please indicate date and time of test and result:
    CL Item
    Positive (Positive)
    CL Item
    Negative (Negative)
    laboratory name
    Item
    Laboratory name, if applicable
    text
    C1882331 (UMLS CUI [1])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial